奥卡西平超说明书用药治疗2岁以下婴幼儿部分发作性癫痫临床观察

目的：研究奥卡西平在儿童癫痫患者中超说明书用药的临床应用效果及其安全性,并为临床制定此类新型抗癫痫药物用药指南提供依据和参考。方法：收集2岁以下婴幼儿癫痫患者75例,进行自身对照开放性研究,给予奥卡西平混悬液根据病情调整用药剂量,观察其临床疗效及不良反应。结果：使用奥卡西平治疗2岁以下婴幼儿部分发作性癫痫的有效率和控制率分别为93．3％和84．0％,不良反应发生率10．7％,主要表现为腹泻、呕吐和皮疹等。结论：奥卡西平在2岁以下婴幼儿部分发作性癫痫患者超说明书用药具有良好的疗效,虽然治疗时会出现轻微不良反应,但相对其他抗癫痫药物仍具有较好的安全性和耐受性。     

奥卡西平治疗癫痫部分性发作的疗效观察

目的：研究新型抗癫痫药物奥卡西平（ oxcarbazepine ）治疗癫痫部分性发作的疗效。方法选取医院于2012年2月－2013年6月门诊收治的100例新诊断癫痫部分性发作患者的临床资料,将其随机分为治疗组和对照组各50例,治疗组采用奥卡西平（ OXC）单药治疗,对照组采用卡马西平（ carbamazepine ）单药治疗,2组患者均治疗6个月,对比2组患者治疗效果及不良反应情况。结果治疗组总有效率为80．0％,对照组总有效率76．0％,差异无统计学意义（P＞0．05）;治疗组不良反应率为14．0％明显低于对照组的30．0％,差异有统计学意义（P＜0．05）。结论奥卡西平在临床治疗癫痫部分性发作具有显著效果,且不良反应小,安全有效。     

左乙拉西坦和奥卡西平单药治疗新诊断儿童部分性癫痫的疗效及安全性分析

目的：观察左乙拉西坦（Levetiracetam,LEV）与奥卡西平（Oxcarbazepine,OXC）单药治疗新诊断部分性发作癫痫患儿的疗效和安全性。方法将68例新诊断部分性发作癫痫患儿随机分为两组,OXC组和LEV组各34例。观察两组的临床疗效、脑电图改变及不良反应。结果OXC组完成治疗32例,LEV组完成治疗34例。临床疗效比较OXC组总有效率为87．5％,LEV组总有效率为85．3％。两组总有效率比较差异无统计学意义（ P＞0．05）。脑电图改善情况比较OXC组有效率为50．0％,LEV组有效率为76．5％,LEV组有效率高于 OXC组,差异有统计学意义（P＜0．05）。 LEV组不良反应发生率低于OXC组,差异有统计学意义（P＜0．05）。结论奥卡西平与左乙拉西坦治疗儿童部分性发作癫痫临床疗效相当,但左乙拉西坦对脑电图改善优于奥卡西平,且不良反应少,安全性更高。     

儿童部分性癫痫一线用药曲莱 口服混悬液登陆中国

5月19日,儿童部分性癫痫一线用药奥卡西平口服混悬液（商品名：曲莱口服混悬液）正式登陆中国市场。曲莱口服混悬液是国家食品药品监督管理局（SFDA）批准的唯一适用于2岁以上儿童部分性癫痫单药治疗的药物,其疗效及耐受性好、不影响认知功能等特性为儿童癫痫治疗带来了新的用药选择。     

奥卡西平与丙戊酸钠对小儿部分性癫痫发作的疗效及其安全性比较

目的:比较奥卡西平与丙戊酸钠对小儿部分性癫痫发作的疗效及其安全性。方法:选取2014年6月—2016年5月间住院治疗的3岁以下小儿部分性癫痫发作患儿78例,采用平行、随机、双盲方法将其分成奥卡西平组(40例)和丙戊酸钠组(38例),分别采用奥卡西平和丙戊酸钠治疗,评价两组患儿治疗后癫痫发作的控制情况、总有效率及不良反应的发生率。结果:两组患儿治疗后脑电图的好转率和总有效率经组间比较其异无统计学意义(P>0.05),不过奥卡西平组患儿治疗后癫痫发作完全控制率和不良反应的发生率优于丙戊酸钠组(P<0.05)。结论:奥卡西平和丙戊酸钠二药抗癫痫发作的总体疗效相近,均可作为备选药品治疗;对于3岁以下婴幼儿部分性癫痫发作均有较好的控制性和安全性,这有助于长期用药,确保治疗的连续性。     

奥卡西平治疗儿童癫痫的临床观察

目的 观察奥卡西平治疗儿童癫痫的疗效.方法 选择69例各种类型癫痫患儿,其中男42例,女27例48例单用奥卡西平治疗为单药治疗组,21例为采用1种或1种以上的其他抗癫痫药物正规治疗,发作未控制而添加奥卡西平治疗者为添加治疗组.起始剂量5～10 mg/(kg·d),每5～7天增加5～10 mg/(kg·d),维持剂量为20～40 mg/(kg·d),每天分2次口服.6个月后进行疗效判定.结果 单药治疗组控制率为66.67％,总有效率为89.58％;添加治疗组控制率为19.05％,总有效率为80.95％.单药治疗组疗效略高于添加治疗组,但差异无统计学意义.结论 奥卡西平治疗儿童癫痫疗效显著,不良反应较少,安全、稳定.     

奥卡西平单药治疗儿童癫痫的临床分析

目的：探讨奥卡西平（OXC）单药治疗不同类型、不同年龄段儿童癫痫的长期疗效和安全性。方法：将32例学龄前期（2~6岁）和36例学龄期（>6~12岁）癫痫患儿根据脑电图检查结果和临床症状分为全面强直阵挛性发作（GTCS）、单纯部分性发作（SPS）、复杂部分性发作（CPS）和继发全面性强直阵挛性发作（SGTCS）四种发作类型,均应用OXC单药治疗。以治疗前3个月癫痫发作的平均频率作为基线,观察治疗后6、12、24个月时的疗效和安全性。结果：68例患儿失访4例,其余64例应用OXC单药治疗24个月后,总控制率和总有效率分别为59.38%和82.81%。随访64例患儿中,共有18例患儿发生不良反应/事件26例次,不良反应/事件总发生率28.13%（18/64）。OXC单药治疗GTCS、SPS、CPS和SGTCS的癫痫症状控制率、总有效率、不良反应/事件发生率比较差异均无统计学意义（P均>0.05）。学龄前期儿童组和学龄期儿童组的癫痫症状控制率比较差异无统计学意义（P>0.05）,但总有效率分别为67.86%和94.44%（P<0.05）,不良反应/事件发生率分别为42.86%和16.67%（P<0.05）。结论：OXC单药治疗GTCS、SPS、CPS和SGTC四种不同发作类型的癫痫患儿,具有相似的长期疗效和安全性,而且学龄期儿童的疗效和安全性优于学龄前期儿童。     

奥卡西平添加治疗成人难治性癫痫部分性发作的疗效分析

目的：探讨临床采用奥卡西平添加对于成人难治性癫痫部分性发作患者的治疗效果以及安全性。方法选择2009年2月到2012年6月期间收治的76例难治性癫痫部分发作患者作为研究对象,患者保持以往抗癫痫药物不变,在此基础上加用奥卡西平进行治疗,观察期为1年,采用自身对照开放性研究,观察该治疗方案的治疗效果、保留率、不良反应发生情况以及安全性。结果69例患者经过12月随访,保留率为90．79％,治疗总有效率为44．93％（31例）,与治疗前比较,总发生频率降低42．11％（χ2＝36．810, P＝0．000）,单纯部分发作癫痫（SPS）发生减少42．32％（χ2＝7．864,P＝0．046）,复杂性部分发作癫痫（CPS）发生减少39．67％（χ2＝7．872,P＝0．047）,部分性发作继全面性发作癫痫（SGS）发生减少41．96％（χ2＝7.869,P＝0．047）,其中34例（49．28％）患者出现嗜睡5例（14．71％）、眩晕3例（8．82％）、头痛13例（38.26％）、恶心6例（17．65％）、注意力不集中2例（5．88％）、疲乏5例（14．71％）等不良反应,均出现在加量期,均为轻中度,不进行特殊的临床处理,停药后自行缓解或者消退。结论奥卡西平对于成人难治性癫痫部分发作治疗效果显著,安全性、耐受性较好,值得在临床上广泛的推广和应用。     

英国DTB评价奥卡西平在癫痫治疗中的作用

英国药物和治疗公报（DTB）对Novartis公司的抗癫痫药奥卡西平（oxcarbazepine，Trileptal）在癫痫治疗中的作用进行了评定，确定本品作为成人和儿童控制不佳的部分性癫痫发作的辅助治疗药能减少癫痫发作的次数。间接比较显示，奥卡西平几乎与其它辅助药物等效，但未对疗效和耐受性进行充分比较。奥卡西平的一个优点是发生药物相互作用的可能性小于卡马西平。奥卡西平用作部分性癫痫发作的单药治疗未与价格较为便宜而临床应用较多的卡马西平和丙戊酸钠等一线药物进行充分比较。DTB建议在不能耐受一线药物时使用奥卡西平。英国DTB评价奥…     

奥卡西平治疗癫痫的临床观察

目的：观察奥卡西平（OCBZ）治疗癫痫的疗效、耐受性和安全性。方法：对36例癫痫患者采用单用和添加奥卡西平治疗,其中19例未经过抗癫痫治疗进入单药治疗组,17例曾使用一线抗癫痫药物无效而进入添加治疗组,两组服用奥卡西平疗程均达6个月。成人起始剂量为剂量为0．15g,qn,维持剂量600～1200mg·d^-1,最大未超过1．5g;儿童按10mg·kg^-1·d^-1,分两次服用,增加剂量每周不超过10mg·kg^-1·d^-1。分两次服用,最大不超过30mg·kg^-1·d^-1。分析两组6月以上的疗效、耐受性和安全性。结果：本组总有效率为88．9％,完全控制为36．1％;其中单药治疗组控制率42．1％,总有效率为94．7％,添加治疗组控制率为29．4％,总有效率为82．4％。最常见的不良反应为头昏、头痛、嗜睡、皮疹、纳差等。单治组不良反应总发生率为31．6％,添加治疗组不良反应发生率为58．8％。结论：奥卡西平治疗癫痫安全、稳定、有效。     

Oxcarbazepine: a review of its use in children with epilepsy

Oxcarbazepine (Trileptal, Timox) is structurally related to carbamazepine and has anticonvulsant activity. Studies suggest that the anticonvulsant activity of oxcarbazepine is mediated via the blocking of neuronal ion channels. In patients aged <18 years, the efficacy of oxcarbazepine monotherapy was similar to that of phenytoin in children with partial onset or generalized tonic-clonic seizures in a 48-week trial. Additional supporting findings demonstrated that 43-71% of patients with partial onset, generalized or undetermined epilepsy were seizure free after oxcarbazepine monotherapy (mean dosage 27.7-50 mg/kg/day; duration 1-5 years). In contrast, one small nonblind trial showed more patients treated with oxcarbazepine monotherapy than with carbamazepine monotherapy had recurrent seizures during 16 months of therapy (although the conclusions that can be drawn from this trial are limited). As adjunctive therapy, oxcarbazepine was significantly better than placebo at reducing seizure frequency in children and adolescents with refractory partial onset seizures with or without secondary generalization: the median percentage change in partial onset seizure frequency was 35% vs 9%, respectively, during 16 weeks of therapy. In noncomparative trials of adjunctive oxcarbazepine (mean dosage of 34.5-56.7 mg/kg/day), 7-11% of patients with partial onset or generalized seizures were seizure free during treatment, and 20-54% had seizure reductions of > or=50%. Oxcarbazepine was generally well tolerated during monotherapy and adjunctive therapy; 2.5% and 10% of patients withdrew from well controlled trials of oxcarbazepine monotherapy and adjunctive therapy. Oxcarbazepine monotherapy was better tolerated than phenytoin and events observed in oxcarbazepine-treated patients were transient. Oxcarbazepine metabolism is largely unaffected by induction of the cytochrome (CYP) P450 system. However, oxcarbazepine can inhibit CYP2C19 and induce CYP3A4 and CYP3A5, thereby interfering with the metabolism of other drugs (e.g. phenytoin). In addition, oxcarbazepine decreases plasma levels of oral contraceptives and alternative contraceptive methods should be used. In conclusion, oxcarbazepine (as both monotherapy and adjunctive therapy) has shown efficacy in the treatment of partial onset seizures in children with epilepsy. Nevertheless, the generally favorable tolerability profile and relatively low potential for drug interactions of oxcarbazepine make it a valuable option in the treatment of childhood epilepsy.     

Spotlight on oxcarbazepine in epilepsy

Oxcarbazepine (Trileptal, Timox) is structurally related to carbamazepine and has anticonvulsant activity. Studies suggest that the anticonvulsant activity of oxcarbazepine is mediated via the blocking of neuronal ion channels. In patients aged <18 years, the efficacy of oxcarbazepine monotherapy was similar to that of phenytoin in children with partial onset or generalised tonic-clonic seizures in a 48-week trial. Additional supporting findings demonstrated that 43-71% of patients with partial onset, generalised or undetermined epilepsy were seizure free after oxcarbazepine monotherapy (mean dosage 27.7-50 mg/kg/day; duration 1-5 years). In contrast, one small nonblind trial showed more patients treated with oxcarbazepine monotherapy than with carbamazepine monotherapy had recurrent seizures during 16 months of therapy (although the conclusions that can be drawn from this trial are limited). As adjunctive therapy, oxcarbazepine was significantly better than placebo at reducing seizure frequency in children and adolescents with refractory partial onset seizures with or without secondary generalisation: the median percentage change in partial onset seizure frequency was 35% versus 9%, respectively, during 16 weeks of therapy. In noncomparative trials of adjunctive oxcarbazepine (mean dosage of 34.5-56.7 mg/kg/day), 7-11% of patients with partial onset or generalised seizures were seizure free during treatment, and 20-54% had seizure reductions of > or =50%. Oxcarbazepine was generally well tolerated during monotherapy and adjunctive therapy; 2.5% and 10% of patients withdrew from well controlled trials of oxcarbazepine monotherapy and adjunctive therapy. Oxcarbazepine monotherapy was better tolerated than phenytoin and events observed in oxcarbazepine-treated patients were transient. Oxcarbazepine metabolism is largely unaffected by induction of the cytochrome (CYP) P450 system. However, oxcarbazepine can inhibit CYP2C19 and induce CYP3A4 and CYP3A5, thereby interfering with the metabolism of other drugs (e.g. phenytoin). In addition, oxcarbazepine decreases plasma levels of oral contraceptives and alternative contraceptive methods should be used. In conclusion, oxcarbazepine (as both monotherapy and adjunctive therapy) has shown efficacy in the treatment of partial onset seizures in children with epilepsy. Nevertheless, the generally favorable tolerability profile and relatively low potential for drug interactions of oxcarbazepine make it a valuable option in the treatment of childhood epilepsy.     

Oxcarbazepine: an update of its efficacy in the management of epilepsy

Oxcarbazepine (10,11-dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide) is a 10-keto analogue of carbamazepine with anticonvulsant activity. In newly diagnosed adult patients, oxcarbazepine monotherapy is as effective as phenytoin and vaiproic acid at reducing generalised tonic-clonic and partial seizure frequency. Furthermore, oxcarbazepine 2400 mg/day as monotherapy has also proved effective in the treatment of refractory partial seizures in adult patients. Oxcarbazepine 600, 1200 and 2400 mg/day as adjunctive therapy significantly reduced seizure frequency compared with placebo in 692 patients with refractory partial seizures. The efficacy of oxcarbazepine monotherapy is similar to that of phenytoin in the treatment of children and adolescents with newly diagnosed partial or generalised tonic-clonic seizures. Additionally, adjunctive therapy with oxcarbazepine was significantly more effective than placebo at reducing seizure frequency in children and adolescents with refractory partial seizures. The most commonly reported adverse events associated with oxcarbazepine monotherapy and/or adjunctive therapy in adults and/or children are somnolence, dizziness, headache, nausea and vomiting. Oxcarbazepine monotherapy is better tolerated than phenytoin (in both adults and children) and valproic acid (in adults), and although 75 to 90% of adult patients in 5 recent monotherapy studies reported adverse events while receiving oxcarbazepine, <8% withdrew from treatment because of them. Acute hyponatraemia, although usually asymptomatic, develops in 2.7% of patients treated with oxcarbazepine. Adverse events most likely to resolve upon switching to oxcarbazepine therapy from treatment with carbamazepine are undetermined skin reactions (rashes, pruritus, eczema), allergic reactions and a combination of malaise, dizziness and headache. Although oxcarbazepine does have a clinically significant interaction with some drugs (e.g. phenytoin and oral contraceptives), it has a lower propensity for interactions than older antiepileptic drugs (AEDs) because its major metabolic pathway is mediated by noninducible enzymes. CONCLUSION: Oxcarbazepine as monotherapy is a viable alternative to established AEDs in the treatment of partial and generalised tonic-clonic seizures in adults and children. Furthermore, it is also effective as adjunctive therapy in the treatment of refractory partial seizures in both age groups. In addition, the drug is tolerated better than the older, established AEDs, and has a lower potential for drug interactions. These attributes make oxcarbazepine an effective component in the initial treatment of newly diagnosed partial and generalised tonic-clonic seizures, and also as an adjunct for medically intractable partial seizures in both adults and children.     

拉莫三嗪单药治疗新诊断小儿局限性癫痫41例疗效观察

目的：探讨拉莫三嗪单药对局限性发作癫痫患儿治疗效果及不良反应。方法首次确诊为部分性发作癫痫患儿41例加用拉莫三嗪治疗12个月,治疗前后分别观察治疗效果及不良反应。结果拉莫三嗪单药治疗41例患儿12个月,总有效率为92.68%,其中完全控制率为80.49%,有效控制率为12.20%,无效控制率为4.88%,不良反应率为9.51%。结论拉莫三嗪是治疗局限性发作癫痫患儿疗效确切、安全性好、可单药使用的药物。     

Oxcarbazepine in the treatment of epilepsy.

Oxcarbazepine is a new antiepileptic drug (AED) that has been registered in more than 50 countries worldwide since 1990 and recently received approval in the United States and the European Union. Oxcarbazepine is a keto analog of carbamazepine and has a more favorable pharmacokinetic profile. It is rapidly absorbed after oral administration and undergoes rapid and almost complete reductive metabolism to form the pharmacologically active 10-monohydroxy derivative. Oxcarbazepine exhibits linear pharmacokinetics, no autoinduction, and minimal interaction with other AEDs. Ten controlled trials demonstrated that oxcarbazepine is safe and efficacious in the treatment of partial seizures across a wide range of ages (children to adults), situations (recent onset to treatment-resistant epilepsy), and uses (monotherapy and adjunctive therapy). The most common treatment-emergent adverse events are related to the central nervous system. Treatment-emergent hyponatremia (defined as serum sodium level < 125 mEq/L) occurred in 3% of patients treated with oxcarbazepine in clinical trials. According to the efficacy and safety profile established in the controlled trials, oxcarbazepine represents an important new treatment option indicated for monotherapy and adjunctive therapy in adults with partial seizures and as adjunctive therapy in children aged 4 years or older with partial seizures. Although structurally similar to carbamazepine, significant differences exist in the pharmacokinetics, drug interaction potential, adverse-effect profile, and dosage and titration between these two agents, and they should be considered distinct therapeutic agents.     

Oxcarbazepine: new preparation. An alternative to carbamazepine in partial epilepsy

(1) The reference treatment for partial epilepsy in adults and children is carbamazepine. (2) Oxcarbazepine is available in the European Union for the treatment of partial epilepsy in adults and children aged over 6 years, alone or in combination with other antiepileptic drugs. (3) The clinical file on oxcarbazepine monotherapy of recent-onset generalised or partial epilepsy mainly contains data from one trial versus carbamazepine, two trials versus phenytoin, and one trial versus valproate sodium. In these trials, 52-60% of patients had no seizures on oxcarbazepine, a proportion not significantly different from that obtained with the comparators. Oxcarbazepine may, in fact, be slightly less effective than carbamazepine. (4) For refractory partial epilepsy (especially forms refractory to carbamazepine), oxcarbazepine is more effective than a placebo, when combined with the inadequately effective treatment, as shown in two trials. Two dose-finding studies show that 2 400 mg/day oxcarbazepine is more effective than 300 mg/day. (5) In trials comparing single-drug treatments there were fewer withdrawals for adverse events among patients on oxcarbazepine than among those on carbamazepine or phenytoin. Compared with carbamazepine, the risk of cutaneous hypersensitivity reactions seems to be lower with oxcarbazepine, while the risk of hyponatraemia is higher. This risk of hyponatraemia necessitates laboratory monitoring. (6) The risk of clinically significant interactions appears to be lower on oxcarbazepine than on carbamazepine, and is limited mainly to combined contraceptives (contraceptive inefficacy) and phenytoin. (7) In practice, carbamazepine remains the reference treatment for partial epilepsy, but oxcarbazepine is one of several second-line options, either alone or in combination with other antiepileptics.     

奥卡西平或卡马西平单药治疗部分性癫痫发作的Meta分析

目的:评价奥卡西平(OXC)和卡马西平(CBZ)治疗部分性癫痫发作疗效和安全性的差异。方法:在Cochrane图书馆、PubMed、中国医院数字图书馆上检索OXC和CBZ单药治疗部分性癫痫发作的随机对照试验(RCT),采用Meta分析专用软件RevMan 5.0.0进行系统评价。结果:共纳入5个RCT,454例部分性癫痫患者,其中A级文献3篇,C级2篇;Meta分析结果显示,OXC组和CBZ组治疗部分性癫痫的总控制率相当,2组比较差异无统计学意义[RR1.09,95%CI(0.73,1.64)];OXC组不良反应(ADR)发生率低于CBZ组[RR0.61,95%CI(0.41,0.91)];OXC组严重ADR退出率也低于CBZ组(RR0.51,95%CI(0.28,0.92))。结论:现有证据表明,OXC治疗部分性癫痫发作疗效并不优于CBZ,但前者安全性更好。     

奥卡西平治疗癫痫自身对照研究

目的观察及评价奥卡西平(OXC)治疗癫痫患者的疗效和安全性。方法对入组的53例患者采用OXC单药或添加治疗,逐渐加量达个体化剂量,尽可能单药治疗。观察52例患者的临床疗效与发作类型、年龄、合并用药种类及发作频率之间的关系(1例因不良反应早期停药);记录并分析不良反应及停药原因。结果OXC治疗癫痫的总有效率为73.1%,完全控制率为32.7%,临床疗效与发作类型、年龄、发作频率无关,合并用药种类越少,疗效越好。13例发生不良反应(发生率24.5%),包括嗜睡、头晕、恶心、皮疹及其它少见的不良反应。结论OXC治疗癫痫疗效肯定,耐受性好,是一种广谱、有效、安全的新型抗癫痫药物。